Tests crizanlizumab against placebo for sickle cell disease pain crises
Tests crizanlizumab or placebo in teens and adults with frequent sickle cell pain crises.
Plain-language title generated from the registry record
Registry title: A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)
Key facts
- Where
- Kampala, Masaka, and Tororo, UgandaSee the 3 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for teenagers and adults with sickle cell disease who often have painful vaso-occlusive crises. It compares crizanlizumab with placebo.
- Age
- 12 years and older (up to 100 years).
- Sex
- All sexes can join.
- Disease stage
- Confirmed sickle cell disease of any genotype, with 4 to 12 vaso-occlusive crises managed by a health care professional in the 12 months before screening.
- Earlier treatment
- If taking hydroxyurea/hydroxycarbamide, at least 6 months of use and a stable dose for at least 3 months before screening. If not taking it, none in the 6 months before screening. Same rule for erythropoietin stimulating agents.
- Biomarker or test result
- Sickle cell disease confirmed by Hb electrophoresis or HPLC.
Main reasons for not taking part
- Fewer than 4 or more than 12 vaso-occlusive crises in the past 12 months
- Earlier stem cell transplant or gene therapy
- Blood products within 30 days before the first dose
- Stroke, brain bleeding or an uninvestigated nerve problem in the past 12 months
- Regular planned transfusion program or planned exchange transfusion during the study
Read by machine on 11 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 100 years old?
Source: NCT06439082, who can take part
Where in Uganda
- KampalaHospital not named in the registryTaking people
- MasakaHospital not named in the registryTaking people
- TororoHospital not named in the registryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT06439082
- Record updated
- 10 November 2026
- Original description
A phase III, multi-center, randomized, placebo-controlled, double-blind study to assess efficacy and safety of crizanlizumab (5 mg/kg) versus placebo, with or without hydroxyurea/hydroxycarbamide therapy, in adolescent and adult Sickle Cell Disease patients with frequent vaso-occlusive crises.Read full original descriptionShow less
A Phase III, Multicenter, Randomized, Placebo Controlled, Double-blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) Versus Placebo, With or Without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients With Frequent Vaso-Occlusive Crises
A phase III, multi-center, randomized, placebo-controlled, double-blind study to assess efficacy and safety of crizanlizumab (5 mg/kg) versus placebo, with or without hydroxyurea/hydroxycarbamide therapy, in adolescent and adult Sickle Cell Disease patients with frequent vaso-occlusive crises.
Inclusion: Participants must be aged 12 years and older on the day of signing informed consent. Adolescents include participants aged 12 to <18 years old and adults include participants aged 18 years and older; Confirmed diagnosis of SCD by Hb electrophoresis or high-performance liquid chromatography (HPLC) (performed locally or by central laboratory if not available locally). All SCD genotypes are eligible; Experienced 4 to 12 VOCs (refer to Section 8.3.1 for study definition of VOC) that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to the screening visit. Baseline VOCs are determined by medical history and are required to be documented at source; If the participant is on HU/HC, they must be taking it for at least 6 months and at stable dose for at least 3 months prior to the Screening visit and plan to continue taking it at the same dose and schedule until at least the participant has reached 52 weeks of the planned study treatment. Participants who have initiated HU/HC 6-12 months prior to the screening visit must have evidence of insufficient control of acute pain despite initiation. These participants must have a cumulative of 4-12 VOCs in the 12 months prior to the screening period, with at least 2 during the last 6 months while on HU/HC. If receiving erythropoietin stimulating agent, the participant must have been receiving the drug for at least 6 months prior to screening visit and plan to continue taking the drug at the same dose and schedule until the participant has reached 52 weeks of the planned study treatment; Participants who have not been receiving HU/HC, and/or erythropoietin stimulating agent must not have received it for at least 6 months prior to screening visit.
Exclusion: Fewer than 4 or more than 12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to screening visit as determined by medical history and documented at source; Received blood products within 30 days prior to Week 1 Day 1 dosing; Any documented history of a clinical stroke or intracranial hemorrhage, or an uninvestigated neurologic finding within the past 12 months before screening visit. Silent infarct only present on imaging is not excluded; History of stem cell transplant and/or gene therapy; Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug or to any excipients of the study drug formulation. History of severe hypersensitivity reaction to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction; Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and/or planning to undergo an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted.